A Safe and Effective Drug for Morning Sickness- A Large New American Study Reports

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MONTREAL, Sept. 16 /PRNewswire/ -- In the latest issue of the
American Journal of Obstetrics and Gynecology, a group of American
and Canadian researchers report on the effectiveness of
Diclectin(R) (the delayed-release formulation of doxylamine and
vitamin B6) for morning sickness.

Morning sickness affects up to 80% of pregnant women, and many
of them need relief from their symptoms to be able to function at
home and at work. The only drug ever approved by the FDA for
morning sickness was Bendectin(R), which was similar to the
presently tested Diclectin(R). Bendectin(R) was removed from the
American market in 1983 due to litigations claiming it caused birth
defects. Large studies involving over 200,000 pregnant women and
their children refuted the claim of fetal risk, and two FDA
committees concurred that Bendectin(R) was safe. Over the ensuing
years, American courts rejected all claims of malformations against
the drug manufacturer. After its removal from the American market,
a Quebec-based Canadian company, Duchesnay, kept producing the drug
in Canada under the name Diclectin(R), where it has been safely and
effectively used for over 30 years.

"We are very pleased that this study adds to the extensive
information available on the efficacy and maternal safety of
Diclectin(R)", stated Eric Gervais, Executive Vice-President of
Duchesnay. "Our product has been available on the Canadian market
for over three decades as the only approved safe and effective
treatment for nausea and vomiting of pregnancy, commonly referred
to as morning sickness. Duchesnay is committed to using this wealth
of clinical information to bring Diclectin(R) to the United States
market. Currently, there is no approved product in the US for the
treatment of this medical condition, forcing pregnant women and
their healthcare professional to seek products whose safety has not
been studied to such an extent."

The present study, conducted as part of the FDA submission for
Diclectin, was carried out in 3 university centers in the US:
University of Pittsburgh, Texas (Galveston), and Georgetown
(Washington DC). All three centers belong to the National Institute
of Child and Human Development from the Obstetric Pharmacology Unit
Network.

"Having a role in making this treatment for nausea and vomiting
of pregnancy is a great moment for me and the entire team. It will
be one of my most significant professional accomplishments." stated
Gary D.V. Hankins, MD, Co-Principal Investigator, University of
Texas Medical Branch, Galveston, Texas.

A total of 280 pregnant women with morning sickness were
randomized to receive either Diclectin(R) or a similar appearing
Placebo. The group receiving Diclectin(R) experienced greater
improvement of morning sickness symptoms and quality of life, and
shorter loss of time from work. Significantly more women receiving
Diclectin(R) asked to continue it after the 2 week trial, as
compared to the Placebo group.

"With the very wide maternal-fetal safety record of this drug
combination, unmatched by any previous drug on the market, we hope
that very soon American women will benefit from a safe and
effective drug for morning sickness after 30 years of being
orphaned from such medication" said Dr. Gideon Koren, the study
lead author and the director of the Motherisk Program in Toronto,
which is a world-leading center for researching and evaluating drug
safety in pregnancy.

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